AstraZeneca: Calquence-based Regimens For CLL Recommended For EU Approval; Discontinues Truqap Trial

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(RTTNews) - British drug major AstraZeneca Plc. (AZN.L, AZN) Tuesday announced the recommendation for European Union approval of a fixed-duration Calquence-based regimens to treat chronic lymphocytic leukaemia or CLL. In a separate statement, the company issued an update on CAPItello-280 Phase III trial of Truqap in metastatic castration-resistant prostate cancer or mCRPC.

AstraZeneca said it is discontinuing the CAPItello-280 Phase III trial based on the recommendation of the Independent Data Monitoring Committee or IDMC that the Truqap combination was unlikely to meet the dual primary endpoints.

The trial was evaluating the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with mCRPC.

A review by IDMC of data from a pre-specified interim analysis concluded that the Truqap combination was unlikely to meet the dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) versus the comparator arm upon trial completion.

The safety profile for Truqap was consistent with previous trials.

AstraZeneca said it will work with investigators to ensure the necessary follow up with patients. Data from the trial will inform ongoing research.

Further, regarding the Calquence, the company announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for approval in the EU for the treatment of adult patients with previously untreated CLL, the most common type of leukaemia in adults.

The recommendation is based on positive opinion on results from the AMPLIFY Phase III trial, which showed Calquence combinations demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to chemoimmunotherapy.

The results showed Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard-of-care chemoimmunotherapy. Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy.

At three years, 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression free, versus 67% of patients treated with chemoimmunotherapy.

The company noted that median progression-free survival was not reached for either experimental arm versus 47.6 months for chemoimmunotherapy.

The AMPLIFY Phase III trial were presented at the American Society of Haematology 2024 Annual Meeting and published in The New England Journal of Medicine.

Regulatory applications for Calquence plus venetoclax, with or without obinutuzumab, in this setting are currently under review in several countries based on the AMPLIFY results.

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